Effect of an Innovative BIO Formula Intake on Infant Growth and Tolerance From 0 to 6 Months

Child Development Clinical Trial

— TRUEGREEN  

Official title:

Evaluation of an Innovative BIO Formula Based on a New Whey Extraction Process on the Growth and Tolerance of Infants From 0 to 6 Months.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936257
• Other study ID #: 2018-A00732-53
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Institut Pasteur de Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

This study, defined as a pilot study, proposes to evaluate the innovative "TrueGreen" BIO infant formula based on a new whey extraction method on the growth and tolerance of infants from 0 to 6 months compared to the conventional BIO infant formula. As no growth and tolerance data are currently available for this new TrueGreen BIO formula, this study aims to determine them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Days

Eligibility

Inclusion Criteria:

• 0 to 3 weeks

• Child followed by a general practitioner or pediatrician

• Informed consent form signed by the legal representatives of the subject

• Commitment of legal representatives to follow the constraints generated by the study

• Insured

Exclusion Criteria:

• Infant born prematurely before 37 weeks of amenorrhea

• Child allergic to cow's milk proteins

• Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);

• Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);

• Incapacity for the legal representative(s) to understand or adhere to the protocol

• Subject involved in another clinical study or in an exclusion period from another study

• Legal representatives deprived of liberty

• Legal representatives in a position to judicial protection

• Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards

• Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards

• BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards

• Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO (World Health Organization) Child Growth Standards

• The investigator considers that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study.

Related Conditions & MeSH terms

• Child Development

Intervention

Other:
• Breastfeeding
Infants were breastfed during 3 months minimum. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
• Conventional BIO Infant formula
Infant were fed during 6 months with a conventional BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
• TrueGreen BIO infant formula
Infant were fed during 6 months with the TrueGreen BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis

Locations

Country	Name	City	State
France	NutrInvest - Institut Pasteur de Lille	Lille	Nord

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur de Lille	Sodiaal International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of growth of infants	Weight in kilograms	from 0 to 6 months
Secondary	Height evolution of infants	data in centimeters	from 0 to 6 months
Secondary	BMI evolution of infants	data in kg/m²	from 0 to 6 months
Secondary	Head circumference evolution of infants	data in centimeters	from 0 to 6 months
Secondary	Number of colic per day	Evaluation during 3 consecutives days every month.	from 0 to 6 months
Secondary	Consistency of stool	Evaluation during 3 consecutive days every month via Bristol scale.; According to the bristol scale, seven types of stool are considered: Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (easy to pass) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid; The mean of stool type during 3 days is considered.	from 0 to 6 months
Secondary	Number of regurgitation	Evaluation during 3 consecutive days every month via Vandenplas scale.; According to the Vandenplas scale, seven score are considered: 0 0-2 episodes/day; =3-=5 of small volume; >5 episodes of >1 coffee spoon; >5 episodes of half of the feedings in < half of the feedings; Continuous regurgitations of small volumes >30 min after each feeding; Regurgitation of half to complete volume of a feeding in at least half of the feedings; Regurgitation of the 'complete feeding' after each feeding; The mean of score during 3 days is considered.	from 0 to 6 months
Secondary	Number of wake up per night	Evaluation during 3 consecutive days every month.	from 0 to 6 months
Secondary	Total sleep time per day	Time in hours. Evaluation during 3 consecutive days every month.	from 0 to 6 months
Secondary	Plasma amino acid profile	Methods : Liquid Chromatography and Tandem Mass Spectrometry (LC / MS / MS) List of amino acids : Taurine, Aspartic acid, Threonine, Serine, Asparagine, Glutamine acid, Glutamine, Glycine, Alanine, Citrulline, Valine, Cystine, Methionine, Isoleucine, Leucine, Tyrosine, Phenylalanine, Beta aminoisobutyric acid, Ornithine, 1-Methyl-Histidine, Histidine, Lysine, 3-methyl-Histidine, Arginine, Hydroxyproline, Proline	between 3rd and 4th month
Secondary	Metabolomic analysis from plasma and urine samples	Non-targeted analysis : evaluation of all small molecules in biological system, such as amino acids, sugars, alcohols, sugar phosphates, amines, fatty acids, polar lipids, hormones and vitamins, as well as specialized metabolites, such as phenolic compounds, flavonoids, monoterpenes, sesquiterpenes, polyketides, alkaloids, including xenobiotics.; Methods : Liquid Chromatography and Mass Spectrometry (LC / MS)	between 3rd and 4th month